PrimeraDx – 2012 Fierce 15

The Scoop: PrimeraDx's ICEPlex is the world's only diagnostic platform that combines two well-known technologies into one benchtop unit, allowing it to test for disparate disease targets without occupying half a lab. The company's innovative work has landed it a companion-diagnostic partnership with Eli Lilly ($LLY), and more high-profile applications are likely to follow.

What Makes It Fierce: PrimeraDx markets ICEPlex, a diagnostic platform that can do what would otherwise require a bevy of benchtop units. The instrument allows for the simultaneous detection and quantification of disparate target types, including mRNA, miRNA, single-nucleotide polymorphisms and DNA. The trick: PrimeraDx's unit combines polymerase chain reaction technology for DNA sequencing with capillary electrophoresis for molecular diagnostics, and it's the only diagnostic tool to do so, the company says.

Plainly, ICEPlex is an all-in-one technology that can be used to develop diagnostics for oncology, infectious disease and the burgeoning field of personalized medicine.

With a platform that powerful, it's no surprise PrimeraDx has attracted some attention of late. The closely held company had in the past been loath to disclose its biopharma partnerships, but over the summer, the Massachusetts company announced a multi-year collaboration with Eli Lilly, with the two planning to develop multiplex assays for the Big Pharma's clinical pipeline. The pair will start with oncology, but neither wanted to put limits on ICEPlex's potential to guide future companion diagnostics, saying instead that they will see where the science takes them.

Most valuable to Lilly, the company says, was ICEPlex's ability to combine multiple DNA and RNA biomarkers into a single multiplex assay. And the platform just got more alluring: Last month, PrimeraDx snagged CE marks for ICEPlex and an accompanying assay designed to detect C. difficile, a common hospital-borne infection that kills about 14,000 people in the U.S. each year.

PrimeraDx has raised about $53 million since its foundation in 2004, and the company is backed by Abingworth, InterWest Partners, Burrill & Company and others.

What To Expect: The development partnership with Lilly is likely to yield some high-profile companion diagnostics in the coming years, but, in the meantime, PrimeraDx is pursuing a two-pronged strategy to sell ICEPlex. On the one end, the company is pitching it as an open platform to clinical labs, and on the other, it's fishing for more pharmas that want to develop high-value companion diagnostics.